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A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, 192-0071 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy female subjects (of childbearing or nonchildbearing potential) and/or male
subjects

- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg and kg.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

? Evidence or history of clinically significant hematological, renal, endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
(history of penicillin hypersensitivity and/or a history of sensitivity to allergens).

NCT03612557
Pfizer
Completed
A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

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A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects
A Phase 1, Open-label Study To Investigate The Pharmacokinetics And Safety Of A Single Intramuscular Injection Of Benzathine Benzylpenicillin In Japanese Healthy Subjects
This will be an open label study to investigate the pharmacokinetics (PK) and safety of a single intramuscular injection of penicillin G benzathine in Japanese healthy subjects.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Drug: penicillin G benzathine
2.4 million units (IM) of benzathine benzylpenicillin
Other Names:
  • penicillin G
  • benzathine benzylpenicillin
Experimental: active treatment arm
penicillin G benzathine treatment
Intervention: Drug: penicillin G benzathine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
8
Same as current
October 28, 2018
October 28, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy female subjects (of childbearing or nonchildbearing potential) and/or male subjects
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg and <100 kg.

Exclusion Criteria:

?Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (history of penicillin hypersensitivity and/or a history of sensitivity to allergens).

Sexes Eligible for Study: All
20 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Japan
 
 
NCT03612557
B8441001
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now